Telix to Showcase ZIRCON Phase III Kidney Cancer Imaging Data and Theranostic Pipeline Developments at SNMMI

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Jun 22, 2023, 07:00 ET

MELBOURNE, Australia, June 22, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces presentations from the Company's investigational prostate (prostate specific-membrane antigen, or PSMA-targeting) and renal (carbonic anhydrase IX, or CAIX-targeting) diagnostic and therapeutic programs at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 Annual Meeting being held in Chicago from June 24 – 27.

Further data from Telix's completed pivotal Phase III ZIRCON study of TLX250-CDx (⁸⁹Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118) will be delivered by Jeremie Calais, MD in an oral presentation.

In addition, Andrew M. Scott, MD will present a preclinical evaluation of Telix's CAIX-targeting radionuclide therapy candidate TLX250 (¹⁷⁷Lu-DOTA-girentuximab) in combination with a Merck KGaA DNA-dependent protein kinase (DNA-PK) inhibitor candidate, peposertib.

SNMMI 2023 will also feature presentations on Telix's lutetium-based, antibody-directed prostate cancer therapy program, ProstACT, and the Company's FDA-approved, gallium-based prostate cancer imaging agent, Illuccix^®, where PSMA imaging with positron emission tomography (PSMA-PET) continues to be a focus for the nuclear medicine and molecular imaging community.

Telix Chief Medical Officer, Dr. Colin Hayward said, "It is fantastic to have such broad representation at this year's SNMMI annual meeting, the premier educational, scientific, research, and networking event in nuclear medicine and molecular imaging worldwide. Alongside further data from the highly successful Phase III ZIRCON study in kidney cancer imaging, we are excited to present latest updates from our ProstACT SELECT and TARGET studies as this program builds momentum into the ProstACT GLOBAL study.

"Preclinical data from a study of Telix's CAIX-targeting therapy candidate TLX250 with an investigational DNA damage response inhibitor will also be presented as this combination prepares to move into the clinic. And last – but by no means least – our approved prostate cancer imaging agent, Illuccix, will feature on the program as part of lifecycle management. Drop by our booth number 4015 to meet with the team, to learn about Telix's deep theranostic pipeline, and to discuss how recent guideline updates for prostate cancer imaging could impact clinical decision making and patient management."

SNMMI oral presentation details are as follows:

Session: Focus on Clinical Studies – New Insights
Title: ¹⁷⁷Lu-TLX591 safety, biodistribution and dosimetry study (ProstACT SELECT)
Date and Time: 24-Jun-2023, 3:45 – 3:55 PM
Presenter: Nat Lenzo, MD (GenesisCare)
Abstract ID: P1145

Session: Urologic Malignancies – Integrated Session
Title: ⁸⁹Zr-DFO-girentuximab PET/CT imaging can accurately detect clear cell renal cell carcinoma (ccRCC) primary and secondary lesions in patients with renal masses at conventional imaging, results from ZIRCON Phase III study
Date and Time: 26-Jun-2023, 10:55 - 11:05 AM
Presenter: Jeremie Calais, MD (UCLA)
Abstract ID: P1113

Session: Imaging and Therapy in Preclinical Oncology Models – Session 2
Title: Addition of DNA dependent protein kinase (DNA-PK) inhibitor peposertib enhances efficacy of ¹⁷⁷Lu-based radioimmunotherapy in pre-clinical models of prostate and renal cell carcinoma
Date and Time: 26-Jun-2023, 11:05 – 11:15 AM
Presenter: Andrew M. Scott, MD (Olivia Newton-John Cancer Research Institute, and La Trobe University)
Abstract ID: P1271

SNMMI poster presentations:

Session: Meet the Author: Oncology: Clinical Therapy & Diagnosis – Group A
Title: Analysis of bone lesions on ⁶⁸Ga-PSMA-11 PET/CT in a randomized controlled trial of men with biochemical recurrence of prostate cancer post prostatectomy
Date and Time: 26-Jun-2023, 11:15 – 11:45 AM
Presenter: David Schuster, MD (Emory University)
Abstract ID: P968

Session: Meet the Author: Oncology: Clinical Therapy & Diagnosis – Group A
Title: External beam therapy with theranostic radioligand therapy for oligometastatic prostate cancer (ProstACT TARGET)
Date and Time: 26-Jun-2023, 11:15 – 11:45 AM
Presenter: Nat Lenzo, MD (GenesisCare)
Abstract ID: P1178

Session: Meet the Author: Oncology: Clinical Therapy & Diagnosis – Group A
Title: 30-second acquisition for Ga-68 PSMA-11 total-body PET/CT impacts prostate cancer management
Date and Time: 26-Jun-2023, 11:15 – 11:45 AM
Presenter: Harshad Kulkarni, MD (BAMF Health)
Abstract ID: P1408

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on Twitter (@TelixPharma) and LinkedIn.

TLX250-CDx, TLX250 and TLX591 have not received a marketing authorisation in any jurisdiction. Telix's lead product, gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),^[1]and by the Australian Therapeutic Goods Administration (TGA),^[2] and by Health Canada.^{^[3]} Telix is also progressing marketing authorisation applications for this investigational candidate in the United Kingdom and the European Union.^[4]

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: [email protected]

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This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website.

^[1] Telix ASX disclosure 20 December 2021.

^[2] Telix ASX disclosure 2 November 2021.

^[3] Telix ASX disclosure 14 October 2022.

^[4] Telix ASX disclosure 3 April 2023.

SOURCE Telix Pharmaceuticals Limited